NDC codes

FDA NDC Directory
Product NDC (as listed)53145-005Labeler and product segments. Claims need a package NDC.
Product NDC at billing width53145-0005Add the package segment from the table below.
Package NDCs as listed with the FDA, and the 11-digit 5-4-2 form used on claims. The highlighted digit is the added leading zero.
Package NDC11-digit (billing)PackageCopy
53145-005-025314500050250 PACKAGE in 1 CARTON (53145-005-02) / 2 TABLET in 1 PACKAGEMarketed from Feb 21, 2012
53145-005-30531450005301 BOTTLE in 1 BOX (53145-005-30) / 30 TABLET in 1 BOTTLEMarketed from Feb 21, 2012

How the 11-digit form is made: The product segment has 3 digits, so one leading zero is added to it (5-3-2 → 5-4-2). Formatting the NDC does not by itself make it billable — the product, package and quantity must match what was dispensed or administered, and payer rules apply. Conversion rules

Product information

Brand name (proprietary)
Defensol D
Generic name (nonproprietary)
acetaminophen, chlorpherinamine maleate, phenylephrine hci
Active ingredients
Acetaminophen — 325 mg/1Chlorpheniramine maleate — 2 mg/1Phenylephrine hydrochloride — 5 mg/1
Dosage form
Tablet
Route
Oral
Product type
Over-the-counter drug
Marketing category
OTC monograph drugApplication M 012
Marketing start
Listing expires
Other FDA classes
Adrenergic alpha1-Agonists (Mechanism)Histamine H1 Receptor Antagonists (Mechanism)
Identifiers
Product ID 53145-005_3a88bd55-586f-64c5-e063-6394a90a6788SPL ID 3a88bd55-586f-64c5-e063-6394a90a6788SPL set ID f466c660-69eb-4581-81ff-1499fa421d8bRxCUI 1046781UNII 362O9ITL9D, V1Q0O9OJ9Z, 04JA59TNSJ
Pharmacologic class
Histamine-1 Receptor Antagonist; alpha-1 Adrenergic Agonist

Billing references

What Med-Code can say about coding this product, and where each statement comes from. Nothing here is inferred from the name alone.

HCPCS codeNo match

No HCPCS code in Med-Code's directory. Oral products like this are usually dispensed by a pharmacy and billed by NDC.

NDC on a medical claim

N453145000502 followed by a unit qualifier and the quantity

Package 53145-0005-02. Unit qualifiers: F2 (international unit), GR (gram), ME (milligram), ML (milliliter), UN (unit (each)). The qualifier and quantity depend on what was given. About the N4 qualifier

Product label

Current FDA label (SPL), effective .

Indications (excerpt from the label)

Uses Temporarily relieves these symptoms associated with cold or flu: headache nasal congestion sore throat fever minor aches and pains Temporarily relieves minor aches, pains and headache as well as these sympotoms of hay fever or other upper respiratory allergies: runny nose sneezing nasal congestion itching of the nose or throat itchy, watery eyes Temporarily relieves minor aches, pains, headache and nasal congestion as well as sinus congestion and pressure, and reduces swelling of nasal passages

Excerpt only. Read the full label for complete information.

Full label on DailyMed (opens in a new tab)

Other NDCs under M 012

Products listed under the same FDA application: other strengths and forms, and repackagers who relabel the same product.

FDA NDC Directory listings under M 012
ProductStrengthForm · routeLabelerProduct NDC
XL-3 Day Timeacetaminophen, dextromethorphan hbr, phenylephrine hclDextromethorphan hydrobromide 10 mg/15mL + 2 more ingredientsLiquidOralRnv LLC84379-441
Halls Sugar Free WatermelonmentholMenthol 2.5 mg/1LozengeOralMondelez Global LLC12546-351
Xpect Cherry Cough Dropscherry cough dropsMenthol 7 mg/1LozengeOralCintas Corporation42961-232
Childrens TYLENOL COLD PLUS COUGH PLUS SORE THROATacetaminophen and dextromethorphan hydrobromideAcetaminophen 160 mg/5mL; Dextromethorphan hydrobromide 5 mg/5mLSuspensionOralKenvue Brands LLC50580-194
Nighttime Cough DMdextromethorphan hbr, doxylamine succinateDextromethorphan hydrobromide 30 mg/20mL; Doxylamine succinate 12.5 mg/20mLSolutionOralL.N.K. International, Inc.50844-043
Diphenhydramine HClDiphenhydramine hydrochloride 50 mg/1Tablet, CoatedOralCVS Pharmacy, Inc.51316-221
DayTime and Nighttime Cold/Flu Relief Softgels - Combo Packacetaminophen, dextromethorphan hbr, phenylephrine hcl, doxylamine succinate—KitARMY AND AIR FORCE EXCHANGE SERVICE55301-605
Sleep Aid NightTimediphenhydramine hclDiphenhydramine hydrochloride 50 mg/30mLLiquidOralDolgencorp, Inc. (DOLLAR GENERAL & REXALL)55910-981
Codeine-Guaifenesincodeine phosphate and guaifenesinCodeine phosphate 10 mg/5mL; Guaifenesin 100 mg/5mLSolutionOralMethod Pharmaceuticals, LLC58657-500
Dual Action Glacier Mint Cough Suppressant Oral AnestheticmentholMenthol 8.3 mg/1LozengeOralRicola USA Inc.63667-603
DayQuil Cold and Flu w/VapoCOOL, 4ct (PE-free), BSXacetaminophen, dextromethorphan hydrobromide tablet, coatedDextromethorphan hydrobromide 10 mg/1; Acetaminophen 325 mg/1Tablet, CoatedOralLil' Drug Store Products, Inc.66715-6204
Multi Symptom Severe Coldacetaminophen, dextromethorphan hbr, phenylephrine hclAcetaminophen 500 mg/1 + 2 more ingredientsPowder, For solutionOralRARITAN PHARMACEUTICALS INC68163-547
Vicks DayQuil Cough DM plus Congestiondextromethorphan hydrobromide, guaifenesin and phenylephrine hydrochlorideDextromethorphan hydrobromide 10 mg/15mL + 2 more ingredientsLiquidOralThe Procter & Gamble Manufacturing Company69423-922
dimaphen dmbrompheniramine maleate, dextromethorphan hbr, phenylephrine hclBrompheniramine maleate 2 mg/10mL + 2 more ingredientsSolutionOralPreferred Pharmaceuticals Inc.68788-8134
Nighttime Cold and Fluacetaminophen, dextromethorphan hydrobromide, doxylamine succinateAcetaminophen 650 mg/30mL + 2 more ingredientsLiquidOralHarris Teeter, LLC69256-343
Cold and Flu Dayacetaminophen, dextromethorphan hbr, phenylephrine hclAcetaminophen 325 mg/15mL + 2 more ingredientsSolutionOralWalgreen Company0363-9912
Multi Symptom Cold and Multi Symptom Nighttime Cold Childrensdextromethorphan hbr, guaifenesin, phenylephrine hci, acetaminophen, diphenhydramine hci, phenylephrine hci—KitCVS Pharmacy69842-820
Allergy Relief Diphenhydramine HCl 25mg SoftGeldiphenhydramine hydrochlorideDiphenhydramine hydrochloride 25 mg/1Capsule, Liquid filledOralPioneer Life Sciences, LLC72090-052
SofSkin Vaporizing Chest Rub and Cough Suppressantcamphor, menthol, eucalyptus oilCamphor (Natural) 4.8 g/100g + 2 more ingredientsOintmentTopicalViny Health and Beauty Inc76436-144
Nighttime Cold and Flu Multi Symptom Reliefacetaminophen, dextromethorphan hbr, doxylamine succinateAcetaminophen 325 mg/1 + 2 more ingredientsCapsule, Liquid filledOralShield Pharmaceuticals Corp83059-0177

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